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J Int Adv Otol 2016 • DOI: 10.5152/iao.2016.2318 Case Report Impression Material in the External and Middle Ear: an Overview of the Literature and a Stepwise Approach for Removal Froukje Verdam, Rinze Tange, Hans Thomeer Department of Otorhinolaryngology, University Medical Center Utrecht, the Netherlands Here, we provide a literature overview of cases with protruding molding material for earplugs or hearing aids and subsequent required treatment, including our own cases. Patients at risk are those with impaired tympanic membranes or who previously underwent otologic surgery. Symptoms such as otalgia, tinnitus, and vertigo are alarming but do not always arise. In case of doubt, a CT scan is of additive value to prepare for adequate surgical removal and to limit potential damage. A stepwise approach for the clinician on how to address these challenging cases is presented, based upon the literature and our own experience. KEYWORDS: (silicone) impression material, middle ear, foreign body INTRODUCTION Over the last two years, three cases were referred to our department with silicone material protruding into the middle ear; the silicone had been applied as a mold to create either adjusted earplugs or hearing aids. In our experience, the prevalence of these incidents is increasing due to the increasing population of hearing aid users. In the case of middle ear involvement, simply attempting to remove the silicone material may cause damage. Patients at risk are those with tympanostomy tubes, perforations, or retraction pockets of the tympanic membrane, as well as patients with a history of mastoidectomy [1]. Notably, this is often exactly the population that requires either earplugs or hearing aids. However, to date, no guidelines have been published on how to address this clinically relevant issue. Here, we describe our own experience; we also provide a review of the literature and a stepwise approach to address these incidents. In the Netherlands, the standard procedure to create custom molds is performed by an audiology assistant. Routinely, a cotton ball is applied in the external meatus, followed by warm, colored silicone material by means of a pistol. If the cotton ball is not applied or if it insufficiently occludes the external ear canal, the silicone material can reach the tympanic membrane and beyond, as illustrated by the next three cases. CASE PRESENTATIONS Case 1 Our first case is a 7-year-old girl with bilateral grommets who underwent earplug adjustment for swimming lessons. Upon introduction of the silicone material, the patient immediately complained of otalgia, and the audiology assistant realized she had forgotten to apply a cotton ball before introducing the silicone impression material. The girl was referred to our center; orange silicone material was observed in both ears. Importantly, the silicone material had caused hearing loss and immediate pain, but no other symptoms. It was not yet clear how deeply the material protruded into the (middle) ear. A high-resolution computed tomography (CT) scan was then performed in order to evaluate the protrusion of the material. The CT scan illustrated that on both sides, the external meatus was obstructed, and the material reached the tympanic membrane without protrusion into the middle ear. After informed consent was obtained, the silicone material was removed without complications. Otoscopy confirmed the (pre-existing) grommets to be in the correct position without damage to the tympanic membrane. Case 2 Our second case is a 20-year-old male who consulted an audiologist to obtain custom earplugs because of his work in a high-noise environment as a baker. Immediately after injection, the patient suffered from otalgia and hearing loss without vertigo or tinnitus. Corresponding Address: Froukje Verdam E-mail: [email protected] Submitted: 06.03.2016 Revision received: 03.08.2016 Accepted: 05.08.2016 Available Online Date: 28.11.2016 ©Copyright 2016 by The European Academy of Otology and Neurotology and The Politzer Society - Available online at www.advancedotology.org J Int Adv Otol 2016 The audiologist attempted to manually remove the mold; this was painful but appeared successful. After no more remnants were detected, the procedure was ceased. However, the patient was referred to our hospital because he still suffered from hearing loss. Microscopic otoscopy showed remaining silicone material surrounding a large tympanic perforation and in his middle ear. Audiology tests confirmed a conductive hearing loss of 30 dB on the left side (Figure 1a). A CT scan was then performed, illustrating that the material had protruded into the middle ear, encasing the stapes and extending into the hypotympanum and facial recess. The material was projected against the horizontal part of the facial nerve, directly adjacent to the horizontal semicircular canal (Figure 1b). The potential risks of hearing impairment, vertigo, and facial nerve damage were explained to the patient, and he was scheduled for surgical removal of the material by post-auricular incision and an endoaural approach six days later. After careful removal of the remaining material in the meatus, we observed the perforation in the tympanic membrane and the material that had flowed into the middle ear (Figure 1c). The remaining silicone material was completely removed, and the ossicular chain and chorda tympani were saved. The eardrum was reconstructed with an underlay fascia temporalis graft. After six weeks, the tympanic membrane was healed and intact. Auditory testing after 6 weeks showed a reduction in conductive hearing loss from 30 to 15 dB and full recovery after 6 months (Figure 1d). Case 3 Our third case was a 41-year-old woman with a previous medical history of a canal wall up mastoidectomy and tympanoplasty of her right ear; the patient had also undergone tympanoplasty with reconstruction of the ossicular chain of the left ear. Three small tympanic membrane perforations were known to persist on the left side. To provide the patient with a conventional hearing aid, a mold was applied, and the material erroneously flowed into the left middle ear of the patient. ENT surgeon attempted to release the mold in a private outpatient clinic. However, manipulation induced vertigo and facial pain. Hence, the patient was referred to our department, and a CT scan was performed. Imaging not only showed material in the external meatus, but also in the middle ear, encasing the stapes (Figure 2a). The patient initially refused to undergo surgery; however, in less than a month, she became motivated and was scheduled for removal under general anesthesia. By means of a combined approach, light blue silicone material was observed in the aditus ad antrum, extending inferiorly into the hypotympanum, encasing part of the previously reconstructed ossicular chain, and lying against the horizontal semicircular canal (Figure 2b). Moreover, the material protruded against the dehiscent facial nerve. Upon further exploration, the material was found to be judiciously elevated from the horizontal part of the facial nerve, the oval window, and the anterior part of the stapes footplate; the remnants are depicted in Figure 2c. Postoperatively, no vertigo was observed, and facial nerve function was normal and symmetrical (bilateral House-Brackmann scale 1). The patient’s hearing impairment, measured 6 months postoperatively, was stable to her pre-operative situ- ation; pre-operative and postoperative audiometry showed a normal perceptive threshold and an airbone gap of 20 dB. DISCUSSION Our described cases with molding material in their middle ear illustrate that after careful examination, diagnostic work up and microsurgical excision, a favorable audiometric result can be accomplished. However, more disadvantageous outcomes have also been reported, such as (persistent) perforations, conductive or sensorineural hearing loss [1-3], vestibular symptoms [2, 4] and a perilymph fistula [5] . This emphasizes the need for low-threshold referral to a center of expertise for this type of pathology. Before the introduction of molding material into the external meatus, it is absolutely necessary both to be informed about the previous medical history of the patient and to perform proper otoscopic evaluation of the tympanic membrane [5, 6]. Extra caution should be taken in the presence of risk factors such as tympanostomy tubes, tympanic membrane perforations, and retraction pockets, and when the patient has a history of previous surgery, such as mastoidectomy [1]. The first case report was published in 1983 [6], and a literature search revealed 40 similar cases published in English, varying only in external or also middle ear involvement [1-17]. Table 1 provides an overview of those 34 cases in the literature with middle ear involvement and for whom the respective (surgical) removal procedures were described. The overview provided in Table 1 includes our two presented cases with middle ear involvement. Reasonably, upon introduction, each mold will induce some conductive hearing impairment. However, other symptoms are less common. In seven cases, there was no description of symptoms upon introduction or removal of the molds [2, 3, 7-9] . Of the remaining 29 cases, acute severe otalgia was reported in 20 subjects (20/29), and 1 patient also suffered facial pain; therefore, these may be considered to be alarm symptoms. In addition, one patient suffered from hematorrhea, dizziness or vertigo was reported in seven patients, and tinnitus was reported in three patients. All of these relatively acute symptoms may be considered alarming, and referral would therefore be indicated. Notably, in cases of delayed presentation, symptoms such as perforation, persistent discharge, and conductive hearing loss may mimic chronic otitis media (n=4) [10, 11]. Manual removal of silicone material is expected to be less harmful in the absence of the risk factors mentioned above. However, cases have been reported of patients with intact tympanic membranes who suffered from hematoma, hematotympanum, or even traumatic tympanic perforation upon extrusion of molds [2, 4-6, 12]. Therefore, even in the absence of risk factors, referral to an ENT/otology department should be considered in the case of acute symptoms upon either introduction or removal of molds. The next step in clinical decision-making is to determine whether imaging (CT scan of the mastoids) should be performed. The extent of the protrusion of material varies greatly in the described population; however, most cases were known to have a medical history of (previous) tympanic membrane perforation (n=27; Table 1). Eight perforations were caused iatrogenically upon either introduction (n=6) or Verdam et al. Molding Material in the Middle Ear Table 1. Overview of reported cases of symptoms, location of the mold, therapy, and complications Author, Original year Age Sex Side indication Symptoms introduction/ removal Risk factor Location in ear 1 Kiskaddon 70 M L Hearing aid, Pain, otorrhea, TM perforation Middle ear et al. (6) presbycusis vertigo, HL surrounding ossicles Surgery Result/remarks Mastoidectomy with facial recess approach, removal 2 Syms and 72 M ? Hearing aid, Unknown Perforation, no Hypotympanum, Transcanal approach Nelson (2) mixed HL, cotton ball Eustachian tube, under local anesthesia; chronic inserted mesotympanum manipulation of the otitis media mass was not well tolerated Complications; acute vertigo, nausea, vomiting, and HL. Profound HL remained, vestibular symptoms resolved in months. 3 58 M L Hearing aid, Unknown Perforations Anterior and mixed HL posterior presbycusis, epitympanum, bilateral COM, entire perforations mesotympanum, bilateral mixed HL Progressive HL of both sensorineural and conductive origin 4 75 F R Transcanal approach under general anesthesia; argon laser was used. A perichondrial graft was used for the TM reconstruction. 1 year after Unknown Perforations Anterior and posterior Facial recess molding hypotympanum, approach, presentation ossicular chain erosion tympanoplasty with discharge No complications, hearing outcome unknown 5 Hof et al. 8 F R and Hearing aid, HL TM perforations (12) L mixed HL, COM and perforations Right: epitympanum, Chordae on the right Postoperative hearing enclosing ossicles, side had to be sacrificed, back to baseline chordae, and crurae ossicles remained intact of the stapes. Ossicilar on both sides chain was preserved. 6 R and L Left: tympanotomy, Ossicles remained intact, Postoperative hearing tympanomeatal flap, material could be back to baseline hypotympanum and removed without mesotympanum complications completely, Eustachian tube. Epitympanum and ossicles were free. 7 Wynne 80 M L Hearing aid, HL, pain TM perforation Small impression into et al. (5) presbycusis the mesotympanum, part of the ossicular chain Left in place. Perforation healed, silicone material remained in the middle ear. No HL. Lost to follow-up after a year. 8 34 M R Hearing aid, HL and pain TM perforation Penetration of the TM Surgical removal and mixed HL upon removal and a large amount of tympanoplasty material resting on the ossicles Perilymph fistula. Surgical closure without relief. Complete vestibular neurectomy after 1 year due to persistent vertigo. 9 Kohan 80 F R Hearing aid, Severe sudden healed TM intact TM, mold in attic, et al. (3) presbycusis otalgia, tinnitus, perforation at encased worsened HL presentation incudostapedial joint (6 months later) Tympanomastoidectomy, facial recess approach, in the attic encasing the inducostapedial joint, mesotympanum, around the long incus process No original audiogram, improvement ABG after removal. Remaining SNHL deterioration. 10 60 M L Hearing aid, Severe otalgia, Traumatic Hypotympanum and presbycusis HL anterior mesotympanum perforation Transcanal middle ear Complete closure of the exploration, mold in ABG and healed hypotympanum and perforation mesotympanum, from eustachian tube to stapes and round window. Tympanoplasty with perichondrium. J Int Adv Otol 2016 Table 1. Overview of reported cases of symptoms, location of the mold, therapy, and complications (continued) 11 60 M L Hearing aid, Unknown. mixed HL, 4-year delay to bilateral presentation. otosclerosis Fenestration Local anesthesia, procedure 23 surgical excision by years previously meatoplasty on the left. 12 9 M L Hearing aid, Acute otalgia, Mastoidectomy Mastoid cavity, narrow radical increased HL EAC mastoidectomy 13 74 M L Hearing aid, Asymptomatic Impaction in viral-induced narrow external SNHL AD as a meatus child on the right, presbycusis AS 14 6 M L Hearing aid, Acute otalgia, Mastoidectomy Mastoid cavity SNHL, HL mastoidectomy AS 16 Jacob 75 M L Hearing aid, HL TM perforation et al. (1) presbycusis No complications Meatoplasty and None transcanal approach, retained cotton wick and mold in the mastoid, posterior to a high facial ridge Attempt to remove Manually/piecemeal under local anesthesia. Painful near TM. Manually removed in second instance by another ENT specialist. Persistent subtotal perforation, 45 dB conductive HL Uncomplicated removal Increased mixed HL from the mastoid bowl without complications under general anesthesia Encasing ossicular Tympanoplasty, middle chain, extending into ear exploration, and the hypotympanum, canal wall up and protruded anteriorly mastoidectomy into the Eustachian orifice 17 75 M R Hearing aid, HL, new onset TM perforation Right: encased the presbycusis pulsatile tinnitus ossicular chain, AD>AS extended inferiorly into the hypotympanum, and protruded into the Eustachian orifice Transcanal tympanoplasty Mixed HL with a widened and middle ear ABG exploration, converted to tympanomastoidectomy facial recess approach because of encasement of the ossicular chain, in particular stapes 18 80 M L Hearing aid, HL Attic retraction Against the pars flaccida presbycusis pocket in the retraction pocket None. Tympanomastoidectomy Enlarged mixed HL was recommended, but the patient refused and was lost to follow-up. 19 53 M L Hearing aid, HL mixed HL 90 minutes of microsopical removal under local anesthesia Prior left canal- External meatus only wall-down mastoidectomy 20 62 M R Hearing aid, Acute pain on None Ruptured tympanic presbyacusis removal of the membrane, silicone mold, HL material in contact with the ossicles 21 8 M L Mold for HL, acute pain Tympanoplasty swimming tube lessons None Refused removal. Persistent ABG 45 dB, Secondary hearing aid cholesteatoma developed; surgical removal was performed in two settings. Incudostapedial joint was separated and the lenticular process e roded (either due to previous removal of mold or caused by the cholesteatoma). Impression in the Removal of the tube, Second postauricular middle ear through the tympanoplasty and tympanoplasty due to tympanostomy tubes, removal of ear mold residual cholesteatoma, not completely around material without damage. no long-term ossicles, not further into Secondary surgery due consequences the middle ear. During to renewed cholesteatoma surgery, a small was performed six cholesteatoma was months later. found. Verdam et al. Molding Material in the Middle Ear Table 1. Overview of reported cases of symptoms, location of the mold, therapy, and complications (continued) 22 Awan 5 M R Mold for Hematorrhea et al. (13) hearing aid and otalgia after SHNL from introduction, birth. No traumatic perforations. perforation Traumatic TM Epitympanum and perforation external meatus upon introduction. Presentation after 3 months; renewed hematorrhea Latrogenic TM perforation, transmeatal approach, embedded malleus which could not be preserved, tympanoplasty Nine years later (patient was indicated for cochlear implantation), remnants in the mastoid antrum (was not explored before) 23 Shashinder 12 M R Hearing aid, Unknown Subtotal bilateral et al. (7) bilateral mixed TM perforations HL, perforations Permeatal removal, chain intact, no damage. Reached into hypotympanum, mesotympanum and Eustachian tube None 24 Dhawan 54 M R Mixed HL, four HL, extreme Not known Meatus, granulation et al. (14) surgical pain beforehand. tissue, a Teflon piston procedures, Clinical and eroded ossicular including presentation remnants, material in modified years after epitympanum, mastoid radical fitting. cavity, aditus mastoidectomy Mastoid exploration revealed tenacious granulations, a piston (Teflon) and ossicular remnants, causing complete occlusion of the middle ear cavity, aditus, and antrum. Dry ear, hearing test was similar to before removal 25 Lee and 46 F R Hearing aid, None TM perforation, Cho (10) bilateral presentation mixed HL after 6 years due to chronic otorrhoea and polyp Tympanomastoidectomy with facial recess approach, ossicular erosion, remnants in Eustachian tube orifice, erosion of the long process of the incus and superstructure of the stapes 26 71 M L Hearing aid, Acute pain and Central mixed HL, vertigo perforation COM Encasing ossicular chain Bilateral TM perforations and extending into Eustachian tube; incus was removed and reshaped between stapes and malleus 27 Leong 74 F L Hearing aid, Discomfort Subluxated stapes, et al. (4) bilateral SNHL impaction in external and middle ear Mold with sponge against eardrum, traumatic TM perforation and a subluxated stapes with a perilymph leak. Bony canal meatoplasty and sealing of the leak. 28 Mitchell 42 M L Occupational Severe sudden History of Protrusion through et al. (15) molds for otalgia and multiple bilateral anterosuperior excessive noise vertigo, HL TM tubes, known perforation, exposure conductive HL during work, on the right and mixed HL mixed HL on the left. Postauricular and transcanal approach, material in Eustachian tube orifice and sinus tympani, encasing all ossicles; resected with CO2 laser and knife. TM reconstruction with cartilage fascia. 29 Saki 69 M R Hearing aid, Otalgia, None; traumatic et al. (16) bilateral severe hematorrhea perforation SNHL 30 Meyers 77 M R Hearing aid, et al. (17) presbyacusis None None, vertigo complaints 3 months after surgery; spontaneous remission. Similar hearing before and after surgery. Traumatic perforation, Postauricular approach, material in external complete removal meatus, middle ear, without damage attic, aditus and Eustachian tube orifice Acute otalgia, TM perforation Post-auricular approach, Mold was fixed between pulsatile tinnitus, mold surrounded the stapes and the facial ear fullness, HL hearing ossicles nerve and intermittent otorrhea for several weeks after fitting Perioperatively, the stapes was dislocated creating a perilymphatic leak, which was solved by means of a fascia graft. No post-operative symptoms. J Int Adv Otol 2016 Table 1. Overview of reported cases of symptoms, location of the mold, therapy, and complications (continued) 31 Algudkar 70 M R Hearing aid, Severe pain and Myringoplasty et al. (11) presbyacusis increased HL for perforation 40 years previously Large central perforation, Removal under general material in external anesthesia, freshening meatus bulging into of the edges of the middle ear. No ossicular perforation chain encasement. 32 Jung 74 F L Hearing aid, Unknown TM perforation Completely filled left et al. (8) mixed HL, middle ear cavity, chronic otitis encasing ossicles, media extending to Eustachian tube, dissociation of stapes-incus joint Perforation and ABG remained, was not motivated for secondary closure Retroauricular approach, canal wall up mastoidectomy, removal of the incus, titanium prosthesis on the stapes foot plate, and tympanoplasty by means of fascia 33 Suzuki 65 M L Hearing aid, Otalgia and Perforations Upon removal of the Removed 5 years later et al. (9) bilateral mixed immediate silicone, the apex of the due to labyrinthitis; the HL, chronic vertigo upon impression broke off and incus was destroyed and otorrhea intrusion remained in the external fistula of the lateral canal. Patient suffered a semicircular canal was left-pointing gaze found. Mastoidectomy nystagmus. Material showed extension into encased auditory the Eustachian tube; the ossicles, including stapes, malleus could not be hypotympanum, and spared. Repaired the Eustachian tube orifice. fistula with a bone chip and subdermal tissue. 34 70 F R Hearing aid, Unknown Canal wall Material filled open mixed HL, mastoidectomy cavity, removal under COM and as a child general anesthesia canal down 8 days later mastoidectomy 35 Current 20 M L Hearing aid, Otalgia and HL TM perforation study mixed HL Encasing stapes, Removal under general None hypotympanum, facial anesthesia, endoaural recess, against facial approach, facial underlay nerve, next to the for TM reconstruction horizontal semicircular canal 36 41 F L Hearing aid, Otalgia, HL, TM perforation Middle ear encasing the mixed HL facial pain after stapes and in proximity tympanoplasty + to the oval window reconstruction of ossicular chain Aditus ad antrum, hypotympanum encasing reconstructed ossicular chain, lying against the horizontal semicircular canal and dehiscent facial nerve ABG: air-bone gap; COM: chronic otitis media; EAC: external auditory canal; HL: hearing loss; SNHL: sensorineural hearing loss; TM: tympanic membrane removal (n=2) of the material. This emphasizes the necessity to use material (such as an otoblock) to occlude the external meatus. To ensure a gradual increase in pressure and to ensure that the material can flow out instead of causing trauma to the tympanic membrane, the application device (such as a pistol) should not be inserted too deeply [12]. If there is clinical suspicion that material may have flowed into the middle ear, or if removal is painful and the condition of the tympanic membrane is unknown, it is advisable to perform a CT scan of the mastoid to 1) prevent collateral damage or complications and 2) establish the extent of protrusion of the molding material. This is pivotal in the presence of risk factors because the molding material can flow with relative ease into the hypotympanum, mesotympanum, and even the Eustachian tube [2, 5, 6, 10, 13]. To safely remove the impression material, four patients could be treated under local anesthesia. In one of these patients, it was necessary to convert and reschedule the procedure for general anesthesia because removal was too painful [1-3]; As a result, microscopic surgery was performed in 33 out of 36 cases. Depending on the location of the material, there was substantial risk of hearing loss and damage to the facial nerve or the semicircular canals. Encountered complications were (persistent) perforations, worsened hearing loss [1-3], and vestibular symptoms [2, 4] (Table 1). One perilymphatic fistula was reported, resulting in a complete vestibular neurectomy a year later due to persistent complaints of vertigo [5]. Transmeatal approaches could be performed in 17 cases, and in all but one case, the material was removed successfully. In the latter case, the material was encountered nine years later in the mastoid antrum when the patient was scheduled for a cochlear implant [13]. Verdam et al. Molding Material in the Middle Ear a b c d Figure 1. Illustrations of Case 2 a-d. Audiometry results showing pre-operative hearing loss (a). Coronal section of the left middle ear, showing encasement of the stapes and positioning adjacent to the facial nerve and the horizontal semicircular canal (b). Peroperative image of the perforation and silicone material in the middle ear (c). Audiometric improvement measured six weeks postoperatively (d) To provide a stepwise approach, we created a decision-making flowchart for clinicians confronted with this intractable clinical phenomenon. It is vital for the audiology assistant applying the mold to be informed of potential risk factors. The assistant should be acquainted with the otologic medical history of the patient and should inspect the tympanic membrane by otoscopy. As mentioned, risk factors include tympanostomy tubes, tympanic membrane perforations, retraction pockets, and a previous history of mastoidectomy. When these risk factors are present, the molding material should be inserted by experienced hands. In cases of otalgia alone and in cases where an intact eardrum is observed beforehand, it can be justified to attempt to release the mold by experienced hands. However, if this procedure increases otalgia or if the condition of the eardrum is in doubt, referral to an ENT specialist is indicated, and a CT scan of the mastoids should at least be considered. When risk factors are present, even greater caution is advised, and any occurrence of symptoms at the time of application or retraction justifies referral and a CT scan, as illustrated in the flowchart in Figure 3. If the CT scan confirms that the molding material is present in the external meatus only, manual removal can be attempted by the ENT physician. However, in cases of doubt or middle ear involvement, we recommend removal under general anesthesia. In conclusion, symptoms such as excessive pain, tinnitus, or vertigo during either insertion or removal of molding material should be considered alarming, and referral is indicated. However, the absence of these symptoms is not a guarantee of adequate placement of the mold, especially in patients with tympanic membrane perforations, retraction pockets, or with a history of otologic surgery. We have pro- J Int Adv Otol 2016 a b c Figure 2. Illustrations of Case 3 a-c. Coronal section of Case 3, showing the stapes covered in material, adjacent to the dehiscent facial nerve and the horizontal semicircular canal (a). Combined approach showing material in the middle ear (b). The remnants after removal (c) Conflict of Interest: No conflict of interest was declared by the authors. Financial Disclosure: The authors declared that this study has received no financial support. Risk factors (yes/no) REFERENCES 1. no: symptoms other than otalgia? yes/unsure: CT yes: CT no: attempt to carefully remove CT in case of more otalgia 2. 3. 4. 5. CT: in external meatus alone? 6. 7. 8. yes: attempt to carefully remove no: removal under general anesthesia 9. Figure 3. Flowchart as a guideline for clinicians. It is pivotal to investigate whether there are known risk factors and whether symptoms have occurred upon either insertion or removal of the molding material. In the absence of risk factors, manual removal may be carefully attempted; however, if this leads to otalgia or other symptoms, a CT scan is indicated to investigate the location of the mold and determine the proper approach for removal 10. vided a clinical guideline on how to address these challenging cases in a flowchart (Figure 3). In cases where middle ear involvement is suspected, a CT scan will be of additive value to determine the appropriate approach for removal. 13. Informed Consent: Verbal informed consent was obtained from patients and the parents of the patient who participated in this study. 15. Peer-review: Externally peer-reviewed. 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